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Arithmetic Training With the Kumon Method for Cognition in Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cognitive training
placebo
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, cognition, arithmetic training, Kumon method

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Literate (≥5 years of formal education).
  • Diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR).
  • Clinically stable, with constant antipsychotic medication regimen for ≥8 weeks before screening
  • No hospitalizations in the last 6 months.

Exclusion Criteria:

  • Other Axis I psychiatric disorders, substance abuse or dependence.
  • History of head trauma or other neurologic diseases.
  • Severe or uncontrolled medical diseases, history of mental retardation or attendance in special-education classes,
  • Suicide risk
  • Participation in any other kind of psychosocial intervention.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    arithmetic training (Kumon method)

    nonspecific recreation

    Arm Description

    Outcomes

    Primary Outcome Measures

    improvement in attention
    neuropsychological battery
    improvement in working memory
    neuropsychological battery
    improvement in executive function
    neuropsychological battery

    Secondary Outcome Measures

    psychopathology
    Evaluation with the Positive and Negative Syndrome Scale (PANSS)
    functioning
    Evaluation with the Personal and Social Performance (PSP) scale

    Full Information

    First Posted
    February 10, 2017
    Last Updated
    February 13, 2017
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03055520
    Brief Title
    Arithmetic Training With the Kumon Method for Cognition in Schizophrenia
    Official Title
    Arithmetic Calculation Training With the Kumon Errorless Learning Method for Cognitive Rehabilitation of Patients With Schizophrenia: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2009 (Actual)
    Primary Completion Date
    June 2010 (Actual)
    Study Completion Date
    June 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    A randomized placebo-controlled trial of arithmetic training (with the Kumon Method) as an errorless learning method for improvement of cognition in schizophrenia. Outpatients were included after signing an informed consent. The trial consisted of 48 sessions of arithmetic training (twice a week, for 6 months) or placebo (nonspecific recreation, 48 sessions). The patients were evaluated with a neuropsychological battery at baseline, after 6 months (end of intervention) and after 12 months after baseline. The Positive and Negative Syndrome Scale (PANSS) and the Personal and Social Performance scale (PSP) were applied at baseline, after 6 months (end of intervention) and 12 months after baseline. Primary outcome was the performance on three cognitive domains (attention, executive functions and working memory).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia
    Keywords
    schizophrenia, cognition, arithmetic training, Kumon method

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    arithmetic training (Kumon method)
    Arm Type
    Experimental
    Arm Title
    nonspecific recreation
    Arm Type
    Placebo Comparator
    Intervention Type
    Other
    Intervention Name(s)
    cognitive training
    Intervention Description
    The Kumon method (www.kumon.com) of arithmetic calculation employs the errorless-learning (EL) strategy and consists of a structured, hierarchical series of exercises, beginning with simple ones (e.g. addition and subtraction) and then proceeding to more complex exercises (e.g. advanced algebra, calculus).
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Intervention Description
    nonspecific recreation including befriending and free simple activities.
    Primary Outcome Measure Information:
    Title
    improvement in attention
    Description
    neuropsychological battery
    Time Frame
    change from baseline to 6 months and to 12 months
    Title
    improvement in working memory
    Description
    neuropsychological battery
    Time Frame
    change from baseline to 6 months and to 12 months
    Title
    improvement in executive function
    Description
    neuropsychological battery
    Time Frame
    change from baseline to 6 months and to 12 months
    Secondary Outcome Measure Information:
    Title
    psychopathology
    Description
    Evaluation with the Positive and Negative Syndrome Scale (PANSS)
    Time Frame
    change from baseline to 6 months and to 12 months
    Title
    functioning
    Description
    Evaluation with the Personal and Social Performance (PSP) scale
    Time Frame
    change from baseline to 6 months and to 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Literate (≥5 years of formal education). Diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR). Clinically stable, with constant antipsychotic medication regimen for ≥8 weeks before screening No hospitalizations in the last 6 months. Exclusion Criteria: Other Axis I psychiatric disorders, substance abuse or dependence. History of head trauma or other neurologic diseases. Severe or uncontrolled medical diseases, history of mental retardation or attendance in special-education classes, Suicide risk Participation in any other kind of psychosocial intervention.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Arithmetic Training With the Kumon Method for Cognition in Schizophrenia

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